1 / 7

ISO 13485 Cerrtification

ISO 13485 defines the Quality Management System (QMS) requirements for organizations involved in the design, development, production, and servicing of medical devices, ensuring safety, consistency, and regulatory compliance.

Digital1019
Download Presentation

ISO 13485 Cerrtification

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. ISO 13485 Certification Medical Devices Quality Management System www.getisocertificate.com

  2. ISO 13485 defines the Quality Management System (QMS) requirements for organizations involved in the design, development, production, and servicing of medical devices, ensuring safety, consistency, and regulatory compliance. Introduction

  3. Demonstrates compliance with international medical device regulations • Improves product reliability and patient safety • Reduces operational risks and non-conformities • Enhances traceability across the device lifecycle • Builds credibility with global healthcare clients Benefits

  4. To maintain consistent quality throughout design and manufacturing • To ensure risk-based control over critical processes • To align with global medical device directives (e.g., EU MDR, FDA) • To enhance customer satisfaction through continuous improvement Objectives

  5. Medical device manufacturers and suppliers • Calibration and testing laboratories • Sterilization service providers • OEMs and contract manufacturers in healthcare Who Can Apply

  6. Specialized expertise in medical device certification • Assistance from documentation to audit coordination • Transparent pricing with zero hidden charges • Certified auditors and implementation professionals • Fast and reliable certification process Why Choose GetISOCertificate

  7. Thank You! Email Contact No Visit Our Website info@getisocertificate.com +91 95400 50215 www.getisocertificate.com

More Related